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Author Topic: Clinical Trial for Failed Harvoni  (Read 6626 times)

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Offline sullyone

  • Newbie
  • Posts: 2
Clinical Trial for Failed Harvoni
« on: January 31, 2017, 05:18:45 pm »
Hello all, I wanted to let you know about a clinical trial for failed Harvoni treatments.  I am genotype 1b.  I was treatment naive when I took Harvoni for 8 weeks, Fibrosure 1 and viral load of 1.1 million.  I never tested undetected, always >15.  After trying to get into multiple studies in multiple states, I located one at the University of Maryland in Baltimore.  (I live in Charleston, SC)  This is not a placebo study, you are given the drug if you participate.  I tested >15 after just 2 weeks, and undetected for the rest of the study. (90 days of treatment)  I had to pay my own airfare, but considering the cost of the drug, it is nothing. I also found the drug to be more tolerable than Harvoni. I will get my 30 day test results later this week and have 2 more trips to be declared cured, but the results are very promising so far.  Anyway, for those of you who are trying to find a way to get treatment and your insurance is no help, please look into this study!  The visits are very short, and the staff is awesome. I fly up and back in the same day, catch the light rail from the airport, and walk the last 7 blocks.  It is so worth it.   https://clinicaltrials.gov/ct2/show/NCT02745535?term=hepatitis+C&recr=Open&state1=NA%3AUS%3AMD&rank=15

Offline spitzbar

  • Member
  • Posts: 25
Re: Clinical Trial for Failed Harvoni
« Reply #1 on: January 31, 2017, 07:46:46 pm »
...the link you provide shows the arms' drug is: Sofosbuvir/Velpatasvir/GS-9857, where voxilaprevir (VOX) is the trade name for GS-9857....google if you doubt.

...the following links elaborate on recent clinical trials and their findings using this same drug, a once-daily, "single" tablet regimen Sofosbuvir/Velpatasvir/GS-9857.

1)  http://hepatitiscnewdrugs.blogspot.com/2017/01/ema-validates-gileads-marketing.html

2)  https://hepatitiscnewdrugs.blogspot.com/2016/12/gilead-submits-nda-to-fda-for.html

3)  http://www.gilead.com/news/press-releases/2016/10/gilead-announces-svr12-rates-from-four-phase-3-studies-of-a-oncedaily-fixeddose-combination-of-sofosbuvir-velpatasvir-and-voxilaprevir-in-treatmentna%C3%AFve-and-treatmentexperienced-genotype-16-chronic-hcvinfected-patients

...you might find this information interesting...truly unfortunate you must travel so far to receive your medication when so many had and continue to have their medication mailed to their front door.

...much success and blessings.

Offline sullyone

  • Newbie
  • Posts: 2
Re: Clinical Trial for Failed Harvoni
« Reply #2 on: January 31, 2017, 07:48:33 pm »
My insurance wouldn't pay for it.  3 appeals, 3 denials.  A clinical trial was my only option.  Thank you for the schooling that I didn't need. 

Offline Lynn K

  • Global Moderator
  • Member
  • Posts: 4,544
  • Get tested, get treated, get cured, fight Hep c!
Re: Clinical Trial for Failed Harvoni
« Reply #3 on: January 31, 2017, 10:52:20 pm »
Hi sullyone and welcome

Congrats on getting into a trial and your results so far wishing you a successful treatment and cure. Thanks for providing information about this trial always great to hear about another option for those fighting with their insurance companies.

And thanks spitzbar for the additional information for other people who may be interested and looking for more information about this exciting option for treatment.
Genotype 1a
1978 contracted, 1990 Dx
1995 Intron A failed
2001 Interferon Riba null response
2003 Pegintron Riba trial med null response
2008 F4 Cirrhosis Bx
2014 12 week Sov/Oly relapse
10/14 fibroscan 27 PLT 96
2014 24 weeks Harvoni 15 weeks Riba
5/4/15 EOT not detected, ALT 21, AST 20
4 week post not detected, ALT 26, AST 28
12 week post NOT DETECTED (07/27/15)
ALT 29, AST 27 PLT 92
24 week post NOT DETECTED! (10/19/15)
44 weeks (3/11/16)  fibroscan 33, PLT 111, HCV NOT DETECTED!


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